Human Factors Design Controls Engineer : 26-01640

Akraya Inc.

Sunnyvale, CA

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JOB DETAILS

SALARY

$70–$72 Per Hour

SKILLS

Control Engineering, Cross-Functional, Documentation, Human Factors, Leadership, Maintain Compliance, Medical Equipment, Product Development, Regulations, Regulatory Compliance, Regulatory Submissions, Risk Analysis, Risk Management, Support Documentation, Technical Recruiting, Technical/Engineering Design, Traceability, Usability Engineering

LOCATION

Sunnyvale, CA

POSTED

17 days ago

Primary Skills: Usability Engineering Documentation (advanced), Risk Analysis (advanced), Design Controls (advanced), Medical Device Regulations (advanced), Polarion (intermediate)
Contract Type: W2 Only
Duration: 12+ Months
Location: Sunnyvale, CA
Pay Range: $70 - $72 per hour on W2

Job Summary:
This role is crucial for ensuring the quality and compliance of medical device development by focusing on human factors and usability engineering. You will be responsible for creating and maintaining essential documentation that supports regulatory submissions and guides the design process. Your work will directly impact the safety and effectiveness of innovative medical technologies.

Key Responsibilities:

Revise and refine risk analysis documentation.
Assist in defining and maintaining design input requirements.
Manage traceability between risks and design inputs using specific tools.
Ensure compliance with relevant regulatory standards.
Collaborate with cross-functional teams on usability aspects.

Must-Have Skills:

Experience with design controls in medical device development.
Proficiency in risk analysis and remediation.
Understanding of medical device regulations.

Experience with the medical device industry is required, with a strong emphasis on product development and regulatory compliance.

ABOUT AKRAYA
Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. Most recently, we were recognized Stevie Employer of the Year 2025, SIA Best Staffing Firm to work for 2025, Inc 5000 Best Workspaces in US (2025 & 2024) and Glassdoor's Best Places to Work (2023 & 2022)!

Industry Leaders in Tech Staffing
As Talent solutions provider for Fortune 100 Organizations, Akraya's industry recognitions solidify our leadership position in the IT staffing space. We don't just connect you with great jobs, we connect you with a workplace that inspires!

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About the Company

Akraya Inc.

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